Cleared Traditional

K211526 - Portable Scalp Cooling System

K211526 is an FDA 510(k) clearance for Portable Scalp Cooling System, manufactured by Cooler Heads Care, Inc.. The device is a Class 2 General & Plastic Surgery device with product code PMC cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K211526 · Cooler Heads Care, Inc. · General & Plastic Surgery device
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Oct 2021
Decision
157d
Days
Class 2
Risk

K211526 is an FDA 510(k) clearance for the Portable Scalp Cooling System. Classified as Scalp Cooling System (product code PMC), Class II - Special Controls.

Submitted by Cooler Heads Care, Inc. (San Diego, US). The FDA issued a Cleared decision on October 21, 2021 after a review of 157 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4360 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Cooler Heads Care, Inc. devices

FDA 510(k) Submission Details - K211526

510(k) Number K211526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2021
Decision Date October 21, 2021
Days to Decision 157 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 115d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PMC Device Classification - Class 2, Special Controls

Product Code PMC Scalp Cooling System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4360
Definition A Scalp Cooling System Is Intended To Reduce Or Prevent The Frequency And Severity Of Alopecia During Chemotherapy In Which Alopecia-inducing Chemotherapeutic Agents Are Used.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

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Pierre Bounaud

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.